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Medical Devices / Submissions and Approvals

Teleflex Gains Premarket Approval for Vascular Closure Device

Feb. 7, 2019

Teleflex’s MANTA, a vascular closure device, received premarket approval by the FDA, and the company plans to launch the device this year.

MANTA is indicated for closing femoral artery access sites while reducing time to hemostasis after the use of sheaths in endovascular catheterization procedures.

The company said a clinical trial of the device successfully hit all primary and secondary endpoints and showed that the product achieves fast, reliable biomechanical closure with rapid hemostasis.

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